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Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after randomization to either continuing on trizivir or combivir, or to switching to Truvada. Measurements include maximal or peak oxygen consumption, lactate production and clearance, subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction in several organ systems.

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:

Change in Peak Oxygen Uptake. [ Time Frame: baseline and 6 months ]

change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.

Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months or Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)

Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)

Other Names:

abacavir

abacavir sulfate

lamivudine

zidovudine

Detailed Description:

None different from the summary description above.

Eligibility

Information from the National Library of Medicine

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